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Merthiolate Benzalkonium Chloride 1.3 mg/mL Liquid, 59 mL — NDC 82645-0912-92 package photo

Merthiolate Benzalkonium Chloride 1.3 mg/mL Liquid, 59 mL

by Pharma Nobis, LLC · 59 mL in 1 BOTTLE (82645-912-92)
NDC 82645-0912-92
🏷️ FDA NDC (as labeled) 82645-912-92 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 82645-912-92
Product NDC 82645-912
11-digit billing NDC 82645091292
RxCUI 1049254
UNII F5UM2KM3W7
UPC 0050428266731, 0635515987432, 0840986030406
Application # M003
SPL Set ID e42f727c-beaf-fe9d-e053-2995a90aafea
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-03-25
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 82645-912-92 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82645-0912-92. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPharma Nobis, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code82645
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio40 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is a topical liquid containing benzalkonium chloride, an antimicrobial agent that is typically used as a skin disinfectant or antiseptic. It is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for its product category rather than being individually approved through a separate application. Benzalkonium chloride is commonly found in antiseptic and disinfectant products intended for topical use on the skin.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1364PS73AF
    Acetone is a clear, volatile liquid solvent. In medications, it helps dissolve or extract active ingredients during manufacturing and may be used in certain liquid formulations or coating processes.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAlcohol 10%, Acetone, FD&C Red No 4, purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Advanced Wound Wash 1.3 mg/mL 00363-9656-10 Walgreens 1 bottle — — FDA listed —
HUMCO Merthiolate 1.3 mg/mL 00395-8010-92 Humco 59 ml — — FDA listed —
Bak 1 750 .1713 g/100mL 12745-0145-01 Medical 473 ml — — FDA listed —
Tincture Merthiolate 1.3 mg/mL 24286-1532-07 DLC 30 ml — — FDA listed —
Puri-San Plus Instant Hand Sanitizer 1.3 mg/mL 43097-0457-10 People's 1000 ml — — Discontinued —
United Airlines .13 g/100mL 52305-0601-25 Freshorize 250 ml — — FDA listed —
Alaska Airlines .13 g/100mL 52305-0602-30 Freshorize 250 ml — — FDA listed —
El Valle Merthiolate 1.3 mg/mL 55758-0375-02 Pharmadel 30 ml — — FDA listed —
safeHands Hand Sanitizer Fragrance Free .13 g/100mL 60867-0150-02 Safehands 52 ml — — FDA listed —
safeHands Hand Sanitizer Clean Linen .13 g/100mL 60867-0152-02 Safehands 52 ml — — FDA listed —
QS Plus Plus Instant Hand Sanitizer 1.3 mg/mL 62257-0457-10 ABC 1000 ml — — Discontinued —
RELEEV Cold Sore Treatment 1.3 mg/mL 63287-0419-01 Merix 1 pouch — — FDA listed —
Quality Choice Merthiolate 1.3 mg/mL 63868-0493-02 Chain 59 ml — — FDA listed —
Soft Care Instant Hand Sanitizer AF .13 g/100mL 64536-3628-03 Diversey, 1300 ml — — FDA listed —
Bactine Max .13 g/100mL 65197-0820-80 WellSpring 1 bottle — — FDA listed —
Cold Sore Treatment, 24-7 Life by 7-Eleven 1.3 mg/mL 66715-5189-00 Lil' 1 bottle — — FDA listed —
Novex Hand Sanitizer 1.3 mg/mL 66902-0037-25 Natural 225 ml — — FDA listed —
Chemcor Chemical Foaming Hand Sanitizer .0013 mg/mL 68041-0519-00 Chemcor 4 bottles — — FDA listed —
Antimicrobial 1.3 ug/mg 68599-0214-04 McKesson 118 mg — — FDA listed —
Zoono Hand Sanitizer .13 g/100mL 69221-0203-11 Zoono 50 ml — — FDA listed —
Zoono Alcohol Free Hand Sanitizer .13 g/100mL 69221-0601-11 Zoono 50 ml — — FDA listed —
CVS Merthiolate 1.3 mg/mL 69842-0749-92 CVS 59 ml — — FDA listed —
ElimiShield Home and Outdoor Moisturizing Hand Sanitizer 1.3 mg/mL 71853-0006-01 Bryson 50 ml — — FDA listed —
U Hand Sanitizer Classic .13 g/100mL 72119-0004-01 BLUE 100 ml — — FDA listed —
Mercurochrome First Aid Antiseptic 1.3 mg/mL 73635-1223-01 Germa 30 ml — — Discontinued —
Merthiolate Tincture First Aid Antiseptic 1.3 mg/mL 73635-1224-01 Germa 30 ml — — Discontinued —
tazza HAND SANITIZER .13 g/.1L 76370-0032-00 Tazza 3.78 l — — FDA listed —
tazza Alcohol-Free sanitizer .13 g/.1L 76370-0041-00 Tazza 1 l — — FDA listed —
Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0001-01 USA 237 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0002-01 USA 237 ml — — FDA listed —
Hygiene Clean Unscented Hand Sanitizer 1.3 mg/mL 80499-0003-01 USA 237 ml — — FDA listed —
Hygiene Clean Pumpkin Spice Hand Sanitizer 1.3 mg/mL 80499-0008-01 USA 50 ml — — FDA listed —
Hygiene Clean Blueberry Lemonade Hand Sanitizer 1.3 mg/mL 80499-0009-01 USA 50 ml — — FDA listed —
Hygiene Clean Leather Oak Hand Sanitizer 1.3 mg/mL 80499-0010-01 USA 50 ml — — FDA listed —
Hygiene Clean Mahogany Teakwood Hand Sanitizer 1.3 mg/mL 80499-0011-01 USA 50 ml — — FDA listed —
Hygiene Clean Bubble Gum Hand Sanitizer 1.3 mg/mL 80499-0012-01 USA 50 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0013-01 USA 50 ml — — FDA listed —
Hygiene Clean Unscented Clean Hand Sanitizer 1.3 mg/mL 80499-0014-01 USA 50 ml — — FDA listed —
Hygiene Clean Balsam Fir Hand Sanitizer 1.3 mg/mL 80499-0015-01 USA 50 ml — — FDA listed —
Hygiene Clean Blueberry Lemonade Hand Sanitizer Car Safe Alcohol-Free 1.3 mg/mL 80499-0017-00 USA 237 ml — — FDA listed —
Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol Free 1.3 mg/mL 80499-0018-00 USA 237 ml — — FDA listed —
Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0030-01 USA 50 ml — — FDA listed —
Hygiene Clean Luxury Clean hand Sanitizer on the go and car safe 1.3 mg/mL 80499-0031-01 USA 50 ml — — FDA listed —
Hygiene Clean Lavender Blossom Hand Sanitizer 1.3 mg/mL 80499-0103-01 USA 50 ml — — FDA listed —
Hygiene Clean Lilac Garden Hand Sanitizer 1.3 mg/mL 80499-0104-01 USA 50 ml — — FDA listed —
Hygiene Clean Spring Bloom Hand Sanitizer 1.3 mg/mL 80499-0105-01 USA 50 ml — — FDA listed —
Purifi Hand Sanitizer .13 g/100mL 80659-0301-01 Purifi 250 ml — — FDA listed —
Merthiolate 1.3 mg/mLthis 82645-0912-92 Pharma 59 ml — — FDA listed —
Caseys .13 g/100g 85844-0001-01 Zhejiang 15 patches — — FDA listed —
Byotrol Hand Sanitizer 1.3 mg/mL 63002-0002-12 Advanced 1250 ml — — FDA listed —
Harris Teeter Spring Fresh Body Wash 1.3 mg/mL 72036-0801-18 Harris 532 ml — — FDA listed —
Tri-Soft Softening 1.3 mg/mL 44577-0711-08 Clinical 236.59 ml — — FDA listed —
Inofoam Antibacterial Foaming Hand Wash 1.3 mg/mL 73062-0032-01 Avro 1 bottle — — FDA listed —
Inofoam Antibacterial Foaming Hand Wash 1.3 mg/mL 73062-0033-01 Avro 1000 ml — — FDA listed —
Mountain Air Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0040-08 K7 236 ml — — FDA listed —
Pine and Honey Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0041-08 K7 236 ml — — FDA listed —
Simply Lavender Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0042-08 K7 236 ml — — FDA listed —
Vanilla Coconut Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0043-16 K7 473 ml — — FDA listed —
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0004-01 USA 237 ml — — FDA listed —
Hygiene Clean Leather Oak Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0005-01 USA 237 ml — — FDA listed —
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0006-01 USA 237 ml — — FDA listed —
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0007-01 USA 237 ml — — FDA listed —
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0025-08 USA 237 ml — — FDA listed —
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0026-08 USA 237 ml — — FDA listed —
Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0027-08 USA 237 ml — — FDA listed —
Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0100-01 USA 800 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0101-01 USA 800 ml — — FDA listed —
Hygiene Clean Luxury Clean Hand Sanitizer 1.3 mg/mL 80499-0102-01 USA 800 ml — — FDA listed —
TopCare Antibacterial Hand Fresh and Clean 1.3 mg/mL 36800-0534-56 Topco 1656 ml — — FDA listed —
Dalan Therapy Antibacterial Hand Wash, Active Protection 1.3 mg/mL 51209-0014-00 DALAN 300 ml — — FDA listed —
Covex Antibacterial Liquid Hand Wash Cool Protection 1.3 mg/mL 51209-0031-03 DALAN 300 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 55319-0633-03 Family 1470 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 62832-0628-96 S. 221 ml — — FDA listed —
Germ Free 24 Hand Sanitizer 1.3 mg/mL 71884-0006-01 Enviro 50 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 75712-0575-96 Old 221 ml — — FDA listed —
Gentlecare Hand And Skin Sanitizer 1.3 mg/mL 78181-0020-02 PARAGON 50 ml — — FDA listed —
FoamFresh E-2 Sanitizer Cleanser 1.3 mg/mL 11429-1002-00 Woodbine 1125 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41250-0628-45 Meijer, 946 ml — — FDA listed —
Tork Hand Sanitizing Alcohol-Free Foam 1.3 mg/mL 49351-0303-01 Essity 1000 ml — — FDA listed —
Covex Antibacterial Hand Wash Active Protection 1.3 mg/mL 51209-0030-03 DALAN 300 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0001-16 Sante 500 ml — — FDA listed —
Hand Wash 1.3 mg/mL 79903-0163-32 Walmart 946 ml — — FDA listed —
Antiseptic Foaming Hand Sanitizer 1.3 mg/mL 82442-0812-20 Target 2 bottles — — FDA listed —
MK BZK Antiseptic Towelette Non-Sterile 1.3 mg/mL 59050-0331-20 Changzhou 100 pouches — — Discontinued —
Ben E. Keith FIHS 1.3 mg/mL 50980-0207-12 Ben 1000 ml — — FDA listed —
Hand Wash 1.3 mg/mL 57243-0001-96 Salado 221 ml — — FDA listed —
Doctor Inks Hand Sanitizer 1.3 mg/mL 71884-0201-01 Enviro 58 ml — — FDA listed —
Biopure Anti-bacterial Hand Wipes Fresh Morning Breeze Scent 1.3 mg/mL 78691-0022-00 Quest 40 patches — — FDA listed —
Harbor Mist E2 Sanitizing Foam with BZK 1.3 mg/mL 81792-0004-01 Von 1250 ml — — FDA listed —
First Aid Only BZK Antiseptic Towelettes 1.3 mg/mL 00924-7115-00 Acme 1.6 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41163-0628-45 United 946 ml — — FDA listed —
Hand Wash 1.3 mg/mL 41250-0661-45 Meijer, 946 ml — — Discontinued —
Dalan Therapy Antibacterial Hand Wash, Fresh Protection 1.3 mg/mL 51209-0016-00 DALAN 300 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 55319-0792-03 Family 1470 ml — — FDA listed —
Antibacterial Foaming Hand Wash 1.3 mg/mL 57243-0628-96 Salado 221 ml — — FDA listed —
KIMBALL MIDWEST Antibacterial Hand Cleaner 1.3 mg/mL 66608-0216-01 Kimball 3785 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0003-32 Sante 947 ml — — FDA listed —
Antibacterial 2X 1.3 mg/mL 71020-0005-02 Sante 2 bottles — — FDA listed —
Antibacterial 2X 1.3 mg/mL 71020-0016-16 Sante 500 ml — — FDA listed —
Biopure Pocket Size Singles Fresh Breeze Scent 1.3 mg/mL 78691-0024-00 Quest 16 packets — — FDA listed —
E-2 Food Processing Foam Hand Wash 1.3 mg/mL 63039-1002-03 Chemco 1000 ml — — FDA listed —
Biopure Anti-bacterial Hand Wipes Honey Wildflower Scent 1.3 mg/mL 78691-0023-00 Quest 40 patches — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 11344-0628-45 Nice-Pak 946 ml — — FDA listed —
Dalan Therapy Antibacterial Hand Wash, Cool Protection 1.3 mg/mL 51209-0015-00 DALAN 300 ml — — FDA listed —
Hand Wash 1.3 mg/mL 55910-0628-45 Old 946 ml — — FDA listed —
Antibacterial Aqua Clear 2X Ultra 1.3 mg/mL 71020-0030-30 Sante 600 ml — — FDA listed —
Hand Wash 1.3 mg/mL 70616-0628-96 Permatex 221 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0004-64 Sante 1900 ml — — FDA listed —
Antibacterial 1.3 mg/mL 76162-0279-03 Topco 1478 ml — — FDA listed —
Foaming Hand Sanitizer 1.3 mg/mL 83986-0118-45 UpLift 1150 ml — — FDA listed —
Covex Antibacterial Hand Wash Fresh Protection 1.3 mg/mL 51209-0032-03 DALAN 300 ml — — FDA listed —
Hand Wash 1.3 mg/mL 53942-0466-45 Demoulas 946 ml — — Discontinued —
X3 Clean Hand Sanitizer 1.3 mg/mL 66902-0038-02 Natural 59 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 68016-0866-45 Pharmacy 946 ml — — FDA listed —
Antibacterial 2X Ultra cleansing 1.3 mg/mL 71020-0020-19 Sante 1900 ml — — FDA listed —
Antibacterial 1.3 mg/mL 71020-0021-32 Sante 947 ml — — FDA listed —
Benzalkonium chloride 1.3 mg/mL 75712-0416-96 Old 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0321-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0317-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0273-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0346-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0373-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0094-45 H 946 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0290-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0252-96 H 221 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0149-45 H 946 ml — — FDA listed —
Benzalkonium Chloride 1.3 mg/mL 59640-0306-96 H 221 ml — — FDA listed —
Mercurochrome 1.3 mg/mL 69469-0013-01 Vitamex 30 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1998
On the market since
Mar 1998
📍
2026
Currently FDA-listed
28 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Merthiolate (this brand).

Top reported reactions

Drug Hypersensitivity122
Arthralgia114
Condition Aggravated114
Pain In Extremity112
Musculoskeletal Stiffness111
Infection110
Musculoskeletal Pain109

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

338 reports
Male · 27%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization175
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 77 5
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82645-0912-92 You're viewing this 59 mL in 1 BOTTLE (82645-912-92) 2017-11-14 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 82645-912-92, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82645-0912-92, written without dashes as 82645091292. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82645-0912-92, the first segment (82645) is the labeler code FDA assigned to Pharma Nobis, LLC; the middle segment (0912) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (92) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pharma Nobis, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharma Nobis, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

Uses first aid to help prevent skin infection in minor cuts, scrapes, burns and insect bites.

⏱️ Dosage and Administration 49 words ▾

Directions adults and children 2 years and older. clean the affected area. apply a small amount on the area 1 to 3 times daily. may be covered with a sterile bandage. if bandaged, let it dry first. children under 2 years of age, do not use, consult a doctor.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active Ingredient Benzalkonium chloride 0.13%

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Alcohol 10%, Acetone, FD&C Red No 4, purified water

🎯 Purpose 2 words ▾

Purpose Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82645-0911-91 · Pharma 82645-0913-16 · Pharma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.